Electrocardiogram (ECG)

electrocardiogram (ECG)

Safety : IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-2-25 Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs IEC 80601-2-49:2018 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors

EMC : IEC 60601-1-2: 2014+AMD1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests CISPR 11:2015 Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement

Performance : IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

Local Standard

USA :

ANSI/AAMI ES60601-1:2005/A2:2021 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance - Amendment 2

21CFR870.2300 MEDICAL DEVICES Subpart C - Cardiovascular Monitoring Devices

ANSI/AAMI/IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests

ANSI/AAMI EC13-2002 Cardiac Monitors, Heart Rate Meters, And Alarms

ANSI/AAMI ES60601-1:2005 (R2012) with amendments Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)

ANSI/AAMI/IEC 60601-2-25:2011 (R2016) Medical Electrical Equipment - Part 2-25: Particular Requirements For The Basic Safety And Essential Performance Of Electrocardiographs

ANSI/AAMI/IEC 60601-2-27:2011 (R2016) Medical Electrical Equipment - Part 2-27: Particular Requirements For The Basic Safety And Essential Performance Of Electrocardiographic Monitoring Equipment

Laser Products. [1040.10]; Specific Purpose Laser Products. [1040.11];

Europe:

EN 60601-1:2006(MAIN) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests

EN 60601-2-25:2015(MAIN) Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

EN 60601-1-2:2015(MAIN) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

EN 60601-2-47:2015(MAIN) Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems

EN 60601-2-27:2014(MAIN) Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

EN IEC 80601-2-49:2019(MAIN) Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment

China:

GB 9706.1: General requirements for safety of medical electrical equipment

GB 4824.1: General requirements for electromagnetic compatibility of medical electrical equipment

GB 21556-2008 Medical electrical equipment - Particular requirements for the basic safety and essential performance of electrocardiographs

GB/T 31467.3-2015 Energy consumption label for electric medical devices - Part 3: Electrocardiographs

Japan:

JIS T 0601-1: General requirements for safety of medical electrical equipment

JIS T 0601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances - Requirements and tests

JIS T 15001-2-49:2017: Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment

JIS T 1501-2:2005 - Electrocardiographs - Part 2: Specific requirements for safety and performance

Korea:

KS IEC 60601-1:2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

KS C 9811 Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement KS C IEC 60601-1-2:2016 is Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests

KS C IEC60601-1-2: Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic disturbances — Requirements and tests

KS C IEC6001-2-25: Medical electrical equipment ─ Part 2-25: Particular requirements for basic safety and essential performance of electrocardiographs

KS C IEC60601-2-27: Medical electrical equipment ─ Part 2-27 : Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

Taiwan:

CNS 60601:2015 Medical electrical equipment - Part 1: General requirements for safety

CNS 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

CNS 14592:2016 Electrocardiographs

Brasil:

ABNT NBR IEC 60601-1:2015 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance

ABNT NBR IEC 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests

ABNT NBR16628 DE 09/2017 Disposable ECG electrodes - Requirements

Mexico:

NOM-IEC 60601-1:2014 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

NOM-IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests

NOM-240-SSA1-2012 Goods and services. Medical equipment. Electrocardiographs. Safety and efficacy specifications and test methods

Argentina:

IRAM 60601-1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IRAM 60601-1-2:2012 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests

IRAM 4220-2-25 Electromedical devices. Part 2-25: Particular safety requirements for electrocardiographs.

IRAM 4220-2-49 Electromedical devices. Part 2-49 - Particular safety requirements for multifunction devices for patient monitoring.

IRAM 4220-2-27 Electromedical devices. Part 2-27: Particular safety requirements for electrocardiographic monitoring devices.

Australia:

AS/NZS IEC 60601.1:2015 Medical electrical equipment, Part 1: General requirements for basic safety and essential performance

AS IEC 60601.1.2:2017 Medical electrical equipment, Part 1.2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests

AS/NZS IEC 60601.2.25:2016 Medical electrical equipment - Part 2.25: Particular requirements for the basic safety and essential performance of electrocardiographs

AS/NZS IEC 60601.2.27:2016 Medical electrical equipment, Part 2.27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

South Africa:

SANS 60601-1:2016 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

SANS 60601-1-2:2022 (Ed. 4.01):Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests 

Saudi Arabia:

SASO IEC 60601-1:2015 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

SASO IEC 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests

GSO IEC 80601-2-49:2021 IEC 80601-2-49:2018 Medical Electrical Equipment - Part 2-49: Particular Requirements For The Basic Safety And Essential

EAEU:

GOST R IEC 60601-1:2017 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

GOST R IEC 60601-1-2:2017 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests

GOST R 56326-2017 Medical equipment. Multifunction patient monitoring equipment. Technical requirements for governmental purchases

GOST R 56326-2014 Medical electrical equipment. Multifunction patient monitoring equipment. Technical requirements for governmental purchases